OncoMatch/Clinical Trials/NCT05635643
Study of CHS-114 in Participants With Advanced Solid Tumors
Is NCT05635643 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including CHS-114 and toripalimab for advanced solid tumor.
Treatment: CHS-114 · toripalimab — This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (results from baseline PD-L1 IHC assay score required)
Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score
Disease stage
Required: Stage III, IV
locally advanced or metastatic (Stage IV) solid tumor; histologically or cytologically confirmed advanced or metastatic HNSCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced/metastatic HNSCC
progressed during or after a platinum-based chemotherapy
Must have received: anti-PD-1 therapy — advanced/metastatic HNSCC
progressed during or after a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent
Must have received: anti-PD-L1 therapy — advanced/metastatic HNSCC
progressed during or after a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent
Cannot have received: CCR8 inhibitor
Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy
Lab requirements
Blood counts
absolute neutrophil count 1.0 10^9/L, hemoglobin 8.0 g/dL, and platelet count 75 10^9/L
Kidney function
Serum creatinine clearance 30 mL/min per Cockcroft-Gault formula
Liver function
Total bilirubin 1.5 ULN ( 3 ULN if elevated because of liver metastases or documented Gilbert's syndrome); AST/SGOT and ALT/SGPT < 2.5 ULN or < 5 ULN for patients with known liver metastases
Cardiac function
Ejection fraction 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality
Serum creatinine clearance 30 mL/min per Cockcroft-Gault formula. Total bilirubin 1.5 ULN ( 3 ULN if elevated because of liver metastases or documented Gilbert's syndrome). AST/SGOT and ALT/SGPT < 2.5 ULN or < 5 ULN for patients with known liver metastases. Adequate hematologic function, defined as absolute neutrophil count 1.0 10^9/L, hemoglobin 8.0 g/dL, and platelet count 75 10^9/L. Ejection fraction 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hoag Memorial Hospital · Newport Beach, California
- FOMAT Medical Research · Oxnard, California
- Stanford Cancer Center · Palo Alto, California
- SCRI Lake Nona DDU (FL Cancer Specialists) · Orlando, Florida
- Emory Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05635643 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CCR8 inhibitor disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify